The WEB-IT Clinical Study

Not Applicable

Completed

Conditions: Intracranial Aneurysms
Wide Neck Bifurcation Intracranial Aneurysms

Interventions: Device: WEB

Registration Number: NCT02191618

Lead Sponsor: Microvention-Terumo, Inc.

Brief Summary: The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 150

Inclusion Criteria

Patient whose age ≥18 and ≤75 years.
Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment.
Patient must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures.

Exclusion Criteria

Patient has an IA with characteristics unsuitable for endovascular treatment
Patient has stroke-in-evolution within the prior 60 days
Patient has had an SAH (subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days
Patient's index IA was previously treated
Patient is pregnant

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WEB Aneurysm Embolization Device	WEB	The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.

Primary Outcome Measures

Name	Time	Method
The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365.	12 months	The study's primary safety endpoint was the proportion of subjects with death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS)) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 days after treatment.
Percentage of Subjects With Complete Aneurysm Occlusion Assessed Using the WEB Occlusion Scale (WOS) Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment	12 months	The primary effectiveness endpoint was defined as the percentage of subjects with complete aneurysm occlusion assessed using the WEB Occlusion Scale (WOS) without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (\>50% stenosis) at one year after treatment in the mITT population.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (32): Riverside Methodist Hospital/ Ohio Health Research Institute
🇺🇸
Columbus, Ohio, United States
Thomas Jefferson University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸
Houston, Texas, United States
National Institute of Neurosciences
🇭🇺
Budapest, Hungary
Radiology Imaging Associates P.C.
🇺🇸
Englewood, Colorado, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
The Mount Sinai Medical Center
🇺🇸
New York, New York, United States
Sequent Medical
🇺🇸
Aliso Viejo, California, United States
Albany Medical Center
🇺🇸
Albany, New York, United States
Marmara University Faculty of Medicine Pendik Training and Research Hospital
🇹🇷
Istanbul, Turkey
Koru Hospital
🇹🇷
Ankara, Turkey
Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Ft. Sanders Regional Medical Center
🇺🇸
Knoxville, Tennessee, United States
Carolina NeuroSurgery & Spine Associates, P.A.
🇺🇸
Charlotte, North Carolina, United States
Helios Hospital
🇩🇪
Erfurt, Germany
Baptist Memorial Hospital
🇺🇸
Memphis, Tennessee, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Methodist University Hospital
🇺🇸
Memphis, Tennessee, United States
West Virginia University
🇺🇸
Morgantown, West Virginia, United States
Rigshospitalet
🇩🇰
Copenhagen, Denmark
Lyerly Baptist, Inc
🇺🇸
Jacksonville, Florida, United States
Johns Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Stony Brook University
🇺🇸
Stony Brook, New York, United States
Buffalo General Medical Center
🇺🇸
Buffalo, New York, United States
Barrow Neurological Institute
🇺🇸
Phoenix, Arizona, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Medical University of South Carolina (MUSC)
🇺🇸
Charleston, South Carolina, United States
University of Utah Medical Center
🇺🇸
Salt Lake City, Utah, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Royal University Hospital
🇨🇦
Saskatoon, Saskatchewan, Canada